Louis Appleby Knew About Prescription Drug-Induced Akathisia in 2004

Louis Appleby Knew About Prescription Drug-Induced Akathisia in 2004

Following on from my previous post, UK Suicide Expert: Akathisia Can Make People Suicidal, it has come to light that the UK's 'expert' on suicide prevention, Prof. Louis Appleby, was warned about prescription drug-induced akathisia many years ago. Just as he does today, he ignored the akathisia and suicide links.

In 2004, Millie Kieve, founder of the APRIL Charity, called the Manchester Coroner's office as there has been a recent Roaccutane suicide. Millie was, and still is, concerned about the reaction of Professor Louis Appleby and why he fails to warn about medicines causing akathisia and suicide risk for some people. Back in 2004, Millie had written to Appleby but he had pretty much ignored her.

Millie recorded the conversation with the Manchester Coroner's office and tells them of her struggles with Louis Appleby. She also tells them that the 2004 suicide strategy plan, headed by Appleby, had no mention of prescription drug-induced suicides or indeed prescription drug-induced akathisia. She tells the Manchester Coroner's office that Appleby's office 'fobbed her off', claiming that "people might get more energy to kill themselves when they take antidepressants."

The call to the coroner sees Millie raise concerns about Appleby, SSRI drugs and other drugs, including Roaccutane, Dianette and Lariam.

This is a huge concern, so much so that MISSD (The Medication-Induced Suicide Prevention and Education Foundation in Memory of Stewart Dolin) an American non-profit organization dedicated to honouring the memory of Stewart Dolin and other victims of akathisia, has now reached out to Appleby on Twitter and have urged him to save lives.

MISSD is a global org dedicated to reducing adverse drug effects. We were glad to reach 100's of docs at our well-received 2019 @rcpsych presentation. @ProfLAppleby please help us save lives.

This 2004 recording shows #akathisia has long been ignored: 

— MISSD (@MISSDFoundation) November 6, 2019

Listen to the 14-minute phone conversation here

Bob Fiddaman

PHE Review Dilutes SSRI Problem

Firstly, I'd like to thank everyone who worked hard to get this review to the table. The list is extensive, you all know who you are.

This post is dedicated to three warriors who were active within the prescribed harm community, they all recently died by prescription drug-induced suicide.

Thank you for fighting the cause:

Jo Dennison

Kata Balint

Shelley Johnson 

This post is in two parts. Part one is about the recent PHE review regarding the evidence for dependence on, and withdrawal from, prescribed medicines in the UK. Part two is about the current suicide 'expert' in the UK, Prof. Louis Appleby, and the president of the Royal College of Psychiatrists, Wendy Burn. Both parts are intertwined, one is about dependency, the other is about self-harm fatalities. I'll also be calling upon the current suicide prevention minister, Nadine Dorries, to carefully consider the serious issues raised here.

Report of the review of the evidence for dependence on, and withdrawal from, prescribed medicines.

Today is World Suicide Prevention Day and Public Health England (PHE) released a public health evidence review of available data and published evidence on the problems of dependence and withdrawal associated with some prescribed medicines.

Coincidence?

PHE review expert reference group members included Yasir Abbasi, Navjot Ahluwalia and Louis Appleby.

Abbasi has received honorarium for advisory board meetings or travel and accommodation for conferences from Indivior Pharma, Martindale Pharma, Bite Medical Pharma and Mundi Pharma.

Indivior market and manufacture Opioid addiction treatment drugs. Martindale, now known as Ethypharm, manufacture a whole host of drugs, including, but not limited to, painkillers. A Google search of Bite Medical Pharma shows no such company, but Bite Medical Consulting do exist. It appears as though they are a communications company. Safe to say that this means they ghostwrite. Some of their clients include Abbot and Lilly, both drug companies who market and manufacture brand and/or generic antidepressants. Mudi manufacture and market addiction medicines.

Ahluwalia carries out expert witness work and is the Executive Medical Director and Consultant Psychiatrist for Rotherham, Doncaster and South Humber NHS Foundation Trust

Appleby is a Professor of Psychiatry who leads the National Suicide Prevention Strategy for England and directs the National Confidential Inquiry into Suicide and Homicide by People with Mental Illness. More about Appleby later.

The Review

The review covered many aspects of prescription drugs, in particular, the withdrawal and dependency problems people face when trying to come off them. There was, however, a mixed message for the SSRI family of drugs.

Benzodiazepines, z-drugs, opioid pain medicines and gabapentinoids are associated with a risk of dependence and withdrawal.

Antidepressants are associated with withdrawal

PHE found that dependency exists on benzos, z-drugs, opioids and gabapentinoids but not antidepressants (SSRIs).

The 152-page review includes a definition of dependence. PHE writes:

Dependence ~ An adaptation to repeated exposure to some drugs and medicines usually characterised by tolerance and withdrawal, though tolerance may not occur with some. Dependence is an inevitable (and often acceptable) consequence of long-term use of some medicines and is distinguished here from addiction.

I'm confused?

Are SSRIs addictive or do people become dependent upon them, or is it neither?

On withdrawal, PHE defines it as: Physiological reactions when a drug or medicine that has been taken repeatedly is removed.

I'm still confused.

Confusion aside, it's nice to see they recognised the daily stigma patients, former patients and drug safety advocates face on a daily basis whenever they publicly share their adverse experiences withdrawing from SSRIs.

The recommendations made by PHE are as follows:

1 ~ Increasing the availability and use of data on the prescribing of medicines that can cause dependence or withdrawal to support greater transparency and accountability and help ensure practice is consistent and in line with guidance.

2 ~ Enhancing clinical guidance and the likelihood it will be followed.

3 ~ Improving information for patients and carers on prescribed medicines and other treatments, and increasing informed choice and shared decision-making between clinicians and patients.

4 ~ Improving the support available from the healthcare system for patients experiencing dependence on, or withdrawal from, prescribed medicines.

5 ~ Further research on the prevention and treatment of dependence on, and withdrawal from, prescribed medicines.

(1) You don't have the data, the drug companies have it. You will never be allowed to see any of the raw data.

(2) You cannot guide if you don't have the data

(3) Where will this information come from?

(4) Improving? This would imply that support is already in place and just needs tweaking. It isn't. It never has been!

(5) Research is meaningless without the raw data

For what it's worth, recommendations are meaningless words. I've written about this terminology before, it gives people false hope and allows those in charge to continue as they were, so to speak. It's not a law, it's not a rule, it's not punishable if prescribers fail to adhere. Call me cynical, but I dare say meaningless recommendations also serve to help systems stall buy some more time to avoid real action.

Back in 2010, a jury at the inquest of Canadian teen, Sara Carlin, returned a list of 17 recommendations. Sara died a violent, akathisia-induced death after ingesting an SSRI known as Paxil in Canada, better known as Seroxat in the UK. These iatrogenic deaths from drug-induced delirium and self harm are typically labeled suicides by coroners. So it is possible Prof. Appleby and organizations purported to reduce suicides could recognize the loss of Sara today. But it is improbable that will happen given Sara's death doesn't help them promote more drugs ("treatments").

Today, nine years after Sara's death, guess how many of those 17 recommendations have been implemented?

None.

Nada.

Zilch.

Sara's death was a kick in the butt for me personally. It made me rethink why I became an advocate/activist. People are dying as a result of taking SSRIs and whilst withdrawal/dependency/addiction (delete where necessary) are important topics, I feel iatrogenic deaths also need to be immediately addressed.

The SSRI withdrawal issue will never be resolved as long as there is no alternative drug in the pipeline waiting to be promoted. In the meantime, the public will continue to be informed of recommendations that are little more than token gestures. These gestures may serve to keep some advocates quiet and give med organizations and rampant prescribers a break from public scrutiny and accountability. As I tweeted early this morning, barbiturates were viewed as having no problems until benzos arrived on the scene. Benzos were viewed as having no problems until SSRIs arrived on the scene. SSRI risks will be played down until a different class of drug arrives on the scene to take a lucrative centre stage.

Don't worry, folks, that may happen sooner than you think. A new way of administering depression treatment is already on the market. Spravato (esketamine) is used as a nasal spray to treat treatment-resistant depression (TRD)

TRD is basically a term used when all else fails or when the drugs a person is currently taking stop working. Janssen, the drug manufacturer, provided the FDA with modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. Now get this, three patients who received the drug died by suicide during the clinical trials, compared with none in the placebo group. But hey, this never stopped the FDA from granting it a licence.

Come back to this blog of mine in 10 years and you'll probably see me writing, "I told you so."

Eventually, and if they have their way, drugs like esketamine will flood the market. Then, and only then, will prescribers speak out en masse about the terrible dependency SSRIs cause.

The Apple That Burns

Earlier I mentioned the three PHE review expert reference group members. The third, Louis Appleby, leads the National Suicide Prevention Strategy for England. He is failing on a grand scale.

A few weeks ago Appleby chastised a member of the prescribed harm community on Twitter. Appleby was soon joined by the Royal College of Psychiatrists leader, Wendy Burn in the condemnation of the website host of antidepaware. The website promotes awareness of the dangers of antidepressants and includes links to reports of inquests held in England and Wales since 2003. The antidepaware author lost a son to SSRI-induced suicide in 2009 and since the creation of the website, in 2014, has tried to make the public aware of the dangers that are, in the main, dismissed by prescribers.

Appleby and Burn were wrong to target a fellow-advocate, particularly given antidepaware has done more than what they have to reduce the ever-increasing rate of suicide in the UK. Many other advocates threw their support behind antidepaware. Appleby, the man who apparently takes all forms of suicide seriously, responded by blocking them. He even blocked parents whose children have died as a result of SSRI-induced suicide.

With this in mind, I threw out a question to both Appleby and Burn on Twitter, a straightforward question that neither has answered despite being asked by me in nine repeated tweets. I have also sent both an email, and both have failed to respond. Here's the question they refuse to answer, or even acknowledge: "Can SSRIs induce death by self-harm?"

One has to ask why Appleby and Burn are refusing to answer a simple, relevant question. Burn in the past has claimed how important informed consent is but when push comes to shove she cannot provide me, or the public for that matter, with an answer regarding whether SSRIs can induce death by self-harm. Instead, Burn's Twitter timeline has been full of Lithium promotion, cat photos, and Play-Doh images.

Both Appleby and Burn need to resign. Appleby's treatment of those who inquire about SSRI-induced deaths has been abhorrent to watch from the sidelines. Burn's failure in recognising the SSRI withdrawal problem also needs to be condemned, as does both of their silence stances surrounding informed consent.

Shortly, I'll be writing to the current suicide prevention minister, Nadine Dorries, to voice my concerns regarding Appleby and Burn. I've written to ministers before and they've been pretty useless in their responses. I don't expect Dorries will intervene but I have an ethical obligation to try.

Suicide Prevention Day is about prevention. By refusing to speak with safety advocates and the bereaved just because their children, wives, husbands, brothers or sisters died iatrogenic deaths does nothing to reduce suicides and increase awareness of adverse drug effects that precipitate these violent, avoidable deaths.

If you want to prevent something from happening, you cover all bases and not just the ones that suit your blinkered views. Shame on Burn and shame on Appleby for keeping me, and others, in the dark regarding informed consent. Informed consent is a basic human right. Without accurate info, there can be no real medical freedom of choice.

On a final note, I want to also condemn Wendy Burn's college in general. On the day when suicide prevention was the paramount message they tweeted the following:

Those online resources they refer to include medications that are associated with suicidal thoughts and suicidal completion. Shame on them.

If you think all of the above is just the rantings of a conspiratorial mad man then read how Wendy Burn and her colleagues treated a fellow psychiatrist when he brought to their attention the dangers of Seroxat, a drug, that after many years he is still trying to withdraw from.

"You’d think that my colleagues would be generally sympathetic. However, I have been marginalised, ignored and vilified as a troublemaker — and a leading member of the RCPsych even wrote to my employer questioning my sanity." ~ Peter Gordon, Psychiatrist

Full story here

Bob Fiddaman

SSRI Deaths in Clinical Trials

Following on from MHRA Yell "Barracuda!", I have sent the following request (under the terms of the Freedom of Information Act) to the MHRA.

I can't see any reason why they can't answer, given they already confirmed to me, in writing, about the 22 deaths that occurred in Paxil clinical trials.

1. How many deaths occurred in the pediatric trials for Paxil/Seroxat. How many were by suicide and how many of those patients were taking Paxil/Seroxat at the time of their death?

2. How many deaths occurred in the pediatric trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

3. How many deaths occurred in the persons aged 24 or over in clinical trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

4. How many deaths occurred in the pediatric trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

5.  How many deaths occurred in the persons aged 24 or over in clinical trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

6. How many deaths occurred in the pediatric trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

7. How many deaths occurred in the persons aged 24 or over in clinical trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

8. How many deaths occurred in the pediatric trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

9. How many deaths occurred in the persons aged 24 or over in clinical trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

Bob Fiddaman

May 6 - One Angel (Sara Carlin) and Paxil

As a writer of factual based evidence, and now fiction (manuscript, 'No Other Man', currently with agent in New York), I often walk into a lot of stories not knowing the ins-and-outs. I sit down and research or, if contacted, I offer people to write guest posts.

Back in 2007, Sara Carlin, a beautiful 18-year-old girl grabbed a piece of electrical wiring, fashioned a crude noose and hanged herself in the basement of her parents house while under the influence of the antidepressant drug Paxil (Seroxat in the UK).

I learned about Sara's plight when I stumbled upon her story in the Oakville Beaver, a Canadian newspaper. At the time, her inquest was approaching and this is when I took an interest.

It was a turning point for me personally and for the direction of this blog. Up until then I had targeted the British drug regulator for their limp-wristed approach to safeguarding the British public.

Sara Carlin changed all of that.

In her death she opened many doors for me. Her inquest, which was basically GSK & Friends Vs The Carlin Family, was reported on in the Canadian press. It was reporting that was biased beyond belief so I took it upon myself to cover the inquest by liaising with Sara's dad after each night of the inquest. I would write what the Canadian press were too afraid to write.

Now, without getting too 'spiritual' and delving into what some might deem as fiction, I was helped along the way by Sara herself. I felt her presence around me and today, which marks the 8th anniversary of her death, I still feel her presence.

In a twist of fate, divine intervention, call it what you will, my son and his wife gave birth to my granddaughter, Ruby-Rose, three years ago. She came into this world on the anniversary of Sara's death.

Sara had a profound effect on my life, she made me realise that this blog shouldn't just be a platform for me to vent my anger toward GSK and the MHRA, it should be a platform for all of those who have lost loved ones due to antidepressant induced suicide and, indeed, those who have lost children to birth defects caused by antidepressants.

As it stands today, my blog is vast approaching one and a quarter million hits, a large chunk of those hits came when I wrote during Sara's inquest. She put me on the map and for that I shall live forever in her debt.

I have become great friends with Sara's parents, Neil and Rhonda. Neil is the brother I never had and when we met in person for the first time some years ago, it was a moment that only a grieving father and passionate writer could fully comprehend. We embraced, cried then talked into the small hours, just Neil, Rhonda and I.

The Carlin family lost their daughter through the incompetence and failure of many. Treating physicians, a lacklustre regulatory system and a pharmaceutical company who chose, and continue to choose, profit over the life of a young woman who had everything to live for.

The inquest saw 16 recommendations made, to date, not one of those recommendations has been put into place. What a slur on the memory of Sara!

Sara Carlin opened my heart and my mind and, as a result, I now report on individual antidepressant induced suicides, or offer guest posts to help the grieving process of those left behind. She gave me the opportunity to give others a voice.

Take a bow angel.

I will be saluting your life later tonight with a bottle of wine.

Nessun Dorma Sara.


Bob (Your dad's soul brother)

This is for the Carlin's, they know what it means.

Back stories



Sara Carlin Inquest – Failure of Oakville Medical Profession

Sara Carlin – ‘Death by Paxil’ Inquest – The ‘Expert’

Sara Carlin Inquest – Coroner’s Witness In U-Turn… And That Man Shaffer!

SARA CARLIN Ontario, Canada

Coroner’s Inquest – Glaxo & Friends Vs The Carlin Family

Sara Carlin Inquest – Local MP Slams GlaxoSmithKline

SARA CARLIN PAXIL INQUEST VIDEO FOOTAGE

SARA CARLIN PAXIL INQUEST GLOBAL TV NEWS

SARA CARLIN INQUEST - What The Jury Should Know

Sara Carlin Inquest - "Paxil likely played important role in teen's suicide"

Sara Carlin Inquest - The Eli Lilly 'Links' & Today's Recommendations.

**Exclusive - Sara Carlin Inquest: The Bias Of Coroner's Counsel, Michael Blain & Coroner, Bert Lauwers

Sara Carlin Inquest - We Know How, Now Tell us Why!

Critics Slam New Antidepressant-Suicide Study

A new study has recently been slammed by fellow professionals in the field of medicine and a top US law firm.

The study, "Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study", was published in the British Medical Journal [BMJ ] last week and, basically, makes outrageous claims based on findings that seem to be based on bizarre methodology.

I had to look up the word 'quasi'  as I didn't know what it meant. I'd assumed for many years it was a shortened version of Quasimodo [ The Hunchback of Notre Dame]

The authors have, it would appear, cherry-picked studies in an attempt to manipulate the outcome.

In a nutshell the authors are suggesting that teenage suicide increased after the FDA toughened antidepressant warning [Black Box Warning]

Two things strike me here.

1. The BMJ is widely read by doctor's, many of whom have been fence-sitting for years regarding the off-label prescribing of antidepressants to children and adolescents. This study is the proverbial splinter up the backside for those doctors, with a sharp prick to the the buttocks they fall from their fence on to the side of the pro-antidepressant brigade.

2. The media reporting of this particular study is worrying. Retired psychiatrist Mikey Nardo, who writes the 1 Boring Old Man blog, breaks the media coverage down...

First the Washington Post (Dennis) reports:

As a result [of the FDA warnings] antidepressant prescriptions fell sharply for adolescents age 10 to 17 and for young adults age 18 to 29. At the same time, researchers found that the number of suicide attempts rose by more that 20 percent in adolescents and by more than a third in young adults.

Comment from a non-study affiliated expert? YES

How many limitations are discussed? NONE

According to NBC News (Raymond) :

New research finds the warning backfired, causing an increase in suicide attempts by teens and young adults. After the FDA advisories and final black box warning that was issued in October 2004 and the media coverage surrounding this issue, the use of antidepressants in young people dropped by up to 31 percent.

Comment from a non-study affiliated expert? NO 

How many limitations are discussed? NONE

Reuters (Seaman) reports that:

Antidepressant use decreased by 31 percent among adolescents, about 24 percent among young adults and about 15 percent among adults after the warnings were issued. At the same time, there were increases in the number of adolescents and young adults receiving medical attention for overdosing on psychiatric medicines, which the authors say is an accurate way to measure suicide attempts. Those poisoning increased by about 22 percent among adolescents and about 34 percent among young adults after the warnings. That translates to two additional poisoning per 100,000 adolescents and four more poisoning per 1,000 young adults, the researchers write.

Comment from a non-study affiliated expert? YES

How many limitations are discussed? ONE (limitation #5)

According to USA TODAY (Painter):

Warnings that antidepressant medications might prompt suicidal thinking in some young people may have backfired, resulting in more suicide attempts, new research suggests.

Comment from a non-study affiliated expert? YES

How many limitations are discussed? NONE

Forbes (DiSalvo) reports:

Antidepressant use fell 31 percent among adolescents and 24 percent among young adults after the FDA warnings, according to the study. Suicide attempts increased by almost 22 percent among adolescents and 33 percent among young adults in the same time period. Suicide attempts tracked in the study were largely the result of drug overdoses.

Comment from a non-study affiliated expert? NO

How many limitations are discussed? NONE

NPR (Stein) also reports on the story:

Antidepressant use nationally fell 31 percent among adolescents and 24 percent among young adults, the researchers reported. Suicide attempts increased by almost 22 percent among adolescents and 33 percent among young adults.

Comment from a non-study affiliated expert? YES

How many limitations are discussed? ONE (limitation #5)

Finally, the Boston Globe (Freyer) concludes that...

instead of declining as hoped, suicide attempts over the next six years showed a “small but meaningful” uptick among people ages 10 to 29, according to a study published Wednesday in the journal BMJ. That increase followed a substantial drop in the use of antidepressants.

Comment from a non-study affiliated expert? YES

How many limitations are discussed? NONE

A perfect proxy for advertising the safety of antidepressant use in kids.

The study, which is open to opinion has, thus far, received a number of comments from fellow-professionals.

Gerald W Gaines, who owns Depression Recovery Centers in Arizona, writes...

" The study presents a statistical association and proposes a causal relationship with no proof and three key assumptions that anti-depressants have efficacy, increases in overdose were due solely to suicide attempts and the two were somehow linked. The study does not demonstrate causality and the preponderance of secondary evidence would suggest there is no causality at all in the way implied."

Worryingly Gaines uses the horse tranquilizer Ketamine to treat his depressed patients.

Peter C Gøtzsche of the Nordic Cochrane Centre in Denmark is highly critical of the study...

"The FDA’s large meta-analysis of 100,000 patients who had participated in placebo-controlled randomised trials found that antidepressants increase suicidal behaviour up till about the age of 40, and in young people, the risk was doubled"

He adds, "The findings in the report by Lu et al. should be ignored. SSRIs don’t decrease suicidal behaviour in young people, as they claim. SRRIs increase it, and it seems that the risk increases with dose, as would be expected."

Associate Professor, Dept. of Family Medicine, McMaster University Dee Mangin,  hits the nail on the head with...

"Almost none of these drugs are licensed for use in depression in this age group. This article could by its implications endorse off-label use."

Psychiatrist Bernard J Carroll of California adds input to the controversial study with, "I won’t even bother to critique the special pleading and the tendentious tone of this report. The decision to publish it was not the BMJ’s finest hour."

While David Healy, Professor of Psychiatry Bangor University, adds, "There is in summary so little basis in the data presented here for the argument being made that this paper perhaps offers better evidence of an agenda than anything else."

It's a pity the mainstream media chose not to ask any of the above professionals for their expert advice, opting instead for sensationalism and eye-catching headlines.

The lead author [instructor] of the study is one Christine Y Lu.

Lu is a  a pharmacist, pharmacoepidemiologist, and health policy researcher. She also mentors students and fellows through the Harvard Medical School Fellowship in Pharmaceutical Policy Research.

Her findings, along with her co-authors, must be a kick in the teeth for the parents who have lost children and other family members to antidepressant induced suicide. Their findings border on moronic given that the methodology used was just a means to widely promote using this group of medications on children and adolescents. At least that's the way I see it... hey I'm an old cynic approaching 50, what do I know?

Even if the study has been criticized they have successfully spread the word without actually lifting a finger.

The BMJ publish it, doctor's read it.

The mainstream press run with it with very few opposing views - the public read it.

Your average family may have been considering their family doctor's offer of an SSRi to help treat their child.

"But don't these drugs cause suicide?"

"No, in fact a new study has shown that suicides have increased since the warning came out... your child is perfectly safe...here's a prescription for Paxil, Zoloft, Celexa, Lexapro, Prozac." [delete where applicable]

I've not yet witnessed a study [so fresh] that has caused so many fellow-professionals outrage. To my knowledge I've never witnessed a law firm come out and chastise the findings of a study so soon after its publication.

Step forward Baum Hedlund, a top US law firm operating out of Los Angeles, Washington, D.C, New Orleans, Philadelphia, and Tallahassee.

They've taken the unusual step of issuing a press release via their webpage.

You can read their full press release here.


In the meantime it's job done for the pro-antidepressant crowd. Their goal may not have been to change the opinion of the FDA, it may have been much simpler. Get the story in a journal widely read by white-coated prescription pad bearers and convince the public [via shoddy journalism] that it's okay to give antidepressants to kids [albeit off-label]

The FDA have issued a statement saying that they have no plans to change the black box warnings [See the Baum Hedlund article for more details.]

Christine Lu has, in my opinion, unleashed a sugar-coated turd. One only has to scratch at the surface to smell the stench. Pinch your nose when going through the study.


Bob Fiddaman.

A Message From RxISK

Have you developed visual problems on anti-depressants, or when stopping them? RxISK.org are looking for those that have.

http://wp.rxisk.org/keeping-an-eye-on-the-ball-visual-problems-on-ssris/

Although the person in the article lists a number of visual symptoms, it is worth noting that their main problem is blurred vision and poor night-vision.

If you experience these problems, please get in touch.

We're very keen to hear from SSRI users, but we would also be happy to hear from other anti-depressant users. You don't have to be based in the UK, providing you can arrange the same testing.

We need to get this message out to as many anti-depressant users as possible. Please help us to spread the word.

Many thanks.

James Bennett (assisting RxISK.org)

Panorama - Antidepressant Birth Defects

Earlier this week the UK flagship programme, Panorama, exposed the link between a group of prescription medications and birth defects. The programme, "The Truth About Pills and Pregnancy", highlighted the epilepsy drug, Epilim (Sodium valporate) and the group of SSRI drugs.

"The Truth About Pills and Pregnancy" focused on two of the SSRi group, namely Cipramil (citalopram) and Seroxat (paroxetine).

Much of what was covered by investigative journalist, Shelley Jofre, has been written about before but rarely do we get the chance to see this controversy on our TV screens.


I'm left wondering if prescribing physicians will see it as putting women off taking medications during pregnancy, this has a tendency to make GP's dig in their heels because professionals hate to be told that they are wrong, they hate to be told that there is research out there that they have missed... overlooked.

Panorama, once again, showed exactly how the pharmaceutical companies, in this case, Sanoi Aventis [Epilim], GlaxoSmithKline [Seroxat] and Lundbeck [Cipramil] deny any link between their products and birth defects. Jofre, who rose to fame for investigative work on Glaxo's Seroxat, also interviewed Dr June Raine, the MHRA's Director of Vigilance and Risk Management. In the past (Panorama Seroxat expose) the MHRA mouthpiece was Alasdair Breckenridge who performed less than adequately in front of camera. Did Raine perform any better? Not really, once again it was all spin and deniability.

The yellow card was touted once again, a system designed to collect adverse reactions to medicines and to protect the public from harm. I don't even believe the MHRA think their yellow card reporting system is robust enough to be the be and end all of dodgy medicines on the market. In any event, children born with defects are just unlucky, right? They are just unfortunate because... well, because shit happens.

Shit is only happening because it's shit that is in charge. However they spin it one must always remember that one cannot polish a turd, something the MHRA have been trying to do for years, particularly where SSRI's are concerned.

The antidepressant/birth defect link has been debated for years. We have those who claim untreated depression in mothers can harm the child, maybe so but there is no evidence that mothers taking antidepressants protect their unborn children by taking these drugs. Yet health professionals globally still prescribe them.

If an illness such as depression in an expectant mother can harm a foetus, does it harm them in such a way that they are born with heart defects, cleft palate or skull deformities?

These are physical changes to the human body caused by the chemicals ingested during pregnancy, we saw it with thalidomide and have been seeing, but ignoring, it for almost two decades with SSRIs.

I don't really buy into this tough decision health professionals have to make, this nonsense about weighing up benefits against risk just doesn't wash with me any more. They should not be weighing up benefit against risk when they don't even have the full facts to compare. Facts, such as the early rat studies [1979/80] carried out on paroxetine - those rats given paroxetine gave birth to pups who all died four days after they were born, while 80% of the pups not exposed to paroxetine were still alive on day four. Surely this should have rang alarm bells or, at the very least, warranted more animal studies. Fact is it didn't, it was brushed under the carpet, seen as something minor, shit happens, right?

When a pharmaceutical company carries out tests on animal subjects they sing from the rooftops when they see a benefit. When they see a risk they bury such data. They do not choose to weigh the two against each other, why would they wish to do something that could harm sales? Harming babies is okay though, just a small price to pay in this billion-dollar market.

Informed Decision

The phrase "informed decision" has been used many times throughout the past 10 years or so that I actually think we have got to the stage where it means nothing, it's just a phrase associated with campaigners, activists or conspiracy theorists. Many won't even know what it means or will accept information given to them by healthcare professionals as everything that needs to be known on the subject. Healthcare professionals tend to quote published studies to concerned patients, studies that have either been funded by the pharmaceutical industry or written by the pharmaceutical industry who later disguise that work as being written by somebody else, usually an expert. Experts who put their names to papers written by the pharmaceutical industry take the back-slaps, along with big payments for being a good sport. It's these weasels who convince doctors that taking antidepressants during pregnancy is quite safe.

One can only make an informed decision when one has all the facts. Truth is, patients never get all the facts - how can they when their own doctors don't?

"The Truth About Pills and Pregnancy" highlighted that almost 20,000 children could have been effected by the epilepsy drug, Epilim. Given that an estimated 1,000 were effected by thalidomide I think it's high time regulators removed their fingers from their backsides and grew a pair. Alas, this is just not going to happen. The MHRA rely on funding from pharmaceutical companies, they rely on expertise from pharmaceutical companies and, in many cases, employ ex-pharmaceutical employees, case in point Alasdair Breckenridge and Ian Hudson, both, at some point in their careers worked for GlaxoSmithKline, or Smith Kline Beecham as they were known then.

Doctors, for their part, maybe have a 10 minute window. A patient will present them with evidence, the doctor will tick boxes and then make a dignosis based on the number of ticks.

In New Zealand, for example, most doctors use PHQ-9, a patient health questionnaire, which carries 9 opportunities for doctors to tick boxes. The patient never gets to see this. Most of the questions relate to if the patient has a poor appetite to if they are overeating, if they are having trouble sleeping or sleeping too much, if they are having trouble concentrating etc. Most, if not all, the questions relate to all of us, probably even the doctor who is running the test on you.

So your doctor allocates you points based on your answers and his observations.

What may surprise many is that the PHQ-9 (patient health questionnaire) is copyrighted to pharmaceutical giants Pfizer, the company that manufactures and markets the antidepressant Zoloft (Sertraline)

Antidepressants are advertised on TV in New Zealand, the only other country that allows this is the United States. The 'other' types of adverts run on TV in New Zealand are letting the public know that it's okay to talk about depression. These ads have a famous face. Ex All Black John Kirwan being the most recent voice/face. Kirwan was, in 2007, appointed as an Officer of the New Zealand Order of Merit for services to mental health and I'm sure, whether he knows it or not, has helped the sales of antidepressant medication.

Taking antidepressants during pregnancy is a hot potato. For expectant mothers it's akin to playing Russian roulette. Their child may be lucky and be born defect free but this does not mean they are out of the woods.

Sudden Infant Death Syndrome (SIDS)

SIDS, more commonly known as cot death or crib death, is not a medical cause of death, rather a statement that the cause of death is unknown. In fact, SIDS, is yet another of those hot potatos as nobody can pinpoint why infants suddenly die when there is, apparently, nothing wrong with them. Some of the theories that exist have been debated and disproved. Bacterial infections, bed sharing, inner ear damage, Nitrogen dioxide exposure, toxic nerve gases emitted by mattresses, high levels of vitamin C have all been used as an explanation or reason for SIDS.

So, most of us know how horrific withdrawal can be on these drugs. We, as adults, have had to endure the electric zaps, tremors, akathesia, suicidal feelings when withdrawing from these drugs - do babies exposed to these drugs during pregnancy experience the same? It would be ridiculous to say that they don't given that smoking and drinking is not recommended during pregnancy because both these substances can harm your child.

The MHRA are having their cake and eating it folks. On one hand they have a clear conscience because they have already told doctors that SSRIs should not be given to children or adolescents because they may induce suicidal thinking in this population. In other words, the risk outweighs any benefit. They are failing miserably in protecting expectant mothers. What the MHRA seem to be forgetting here [conveniently] is that it's not just one person ingesting the medication, it's two and one of them falls into the very same category (population) that the MHRA, after many years of thumb-twiddling, found that the risk of antidepressant exposure far outweighs any benefit.

Now, tell me again, what benefit does a child growing inside its mother receive from an antidepressant, indeed, tell me, if you will, what benefit a newborn receives from breast feeding when traces of antidepressants have been found in breast milk?

If you are an expectant mother and still undecided about antidepressant use during pregnancy then this simple test should help you arrive at your decision. If you feel the need to bathe your unborn child in serotonin then drop a bronze coin into a glass of Coke and see what happens.

"The Truth About Pills and Pregnancy" can be viewed below. It may only be available on YouTube for a short period as the material belongs to the BBC. I made the decision to upload it for the benefit of viewers outside the UK who cannot access the BBC IPlayer.

Bob Fiddaman

Mimicking Depression: The Wrong Diagnosis

A lot has been said on the use of antidepressants and whether they are safe and effective in those that use them.

The majority of healthcare professionals who prescribe these medications on a daily basis seem to think that antidepressants have a place in today's society. The majority prescribe them because they have been told, and are still told, that they are safe and effective.

Of course, your average GP doesn't just think that the evidence that these drugs work is based around the clinical trials, spokespersons of pharmaceutical companies and thought leaders. They, apparently, see the results first hand. Depressed Joe feels a whole lot better because of the Prozac that Dr Jones prescribed him 2 months ago. The change in Joe is enough for his Dr to believe that the Prozac is working. The placebo effect rarely enters the mind of Joe or Dr Jones.

I find the history of marketing antidepressant medication fascinating in as much that it is rarely questioned by the masses, even if it was questioned by your average layperson it's, more often than not, met with a shrug of the shoulders and an 'Ah well' attitude.

It couldn't happen to me, right? I'd never allow myself to become depressed, to take an antidepressant people must be weak, why don't they just get a grip of themselves?

Attitudes like this may have there place but the genius of pharma marketing is that they are very convincing but always driven by profit.

Who Cares About Sweden Trilogy - The SSRi Swindle

A great set of videos to watch regarding the dangers of SSRi's.

"Who Cares About Sweden" released by ARTIMUS Film SVB AB will make you angry, sad, frustrated and all the other emotions one faces when realization sets in about how we, as consumers, have been duped by the pharmaceutical industry and the field of psychiatry.

Actos With SSRi - Complete Madness!

An article appeared in yesterday's Daily Mail highlighted a published paper that suggested taking Pioglitazone [Actos] in conjunction with SSRi's could boost the effect of the antidepressant.

SSRi's, such as Seroxat, Cipramil, Prozac!

The study, published in Neuropsychopharmacology, an international scientific journal, is yet another example of poor research skills by the authors of the paper and by the journal itself.

Actos, manufactured by Japanese company, Takeda Pharmaceuticals, has recently hit the headlines in the US for causing bladder cancer in patients. Many lawsuits have been filed, not to mention the lives that have been damaged by the prolonged use of this particular diabetes medication.

As for SSRi medication, well we all know how dangerous they can be and we all know how the UK regulator likes to play down those dangers such as suicide, akathesia, homicidal thoughts and horrendous withdrawal problems.

When studies, such as the one in Neuropsychopharmacology appear, it would be of huge benefit if the UK regulator, the MHRA, actually wrote to the authors or the journal to warn them of the bladder cancer risk with Actos. A 2011 warning on their website does not cover them in garlands neither does it alter the fact that they are responsible for safeguarding human health, a line that they proudly boast at every given opportunity.

I'd write to them if I thought it would make a blind bit of difference but to be honest I'm sick and tired of their worn out phrase that the 'benefits outweigh the risks'.

No doubt doctor's up and down the country will have been told that Actos is not recommended...but they can still prescribe it if they believe the benefits outweigh the risk.

To even suggest that it could be useful if used in conjunction with SSRi's will have tapped into the psyche of those that read it. There are still doctor's that won't know about the Actos bladder cancer link and I know for a fact that there are still doctors who utterly refute any suicide link with antidepressants, they are normally the ones who like to think that the patient is never right.

The editors at Neuropsychopharmacology should, at the very least, add a warning to the recent paper, particularly when the risk of bladder cancer is 40 percent greater in patients taking Actos for longer than one year.

More about Actos and the bladder cancer link HERE





Fid


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2012 - The Year of Dr David Healy

Internationally respected psychiatrist, psychopharmacologist, scientist, and author Dr David Healy has been busy of late. The launch of two new websites [one in blog form] and a book has got people talking in the blogsphere and on Twitter.

For those who don't know, Healy became a household name in the advocacy circles when he first spoke out about antidepressant use, particularly those of the SSRi family, of which Seroxat is one. He has been used as an expert witness in many cases against the pharmaceutical industry and, to my knowledge, is the only UK based health professional who has got to grips with the whole SSRi withdrawal issue, even offering tapering regimes for those who are struggling with their, apparent, non-addictive medication.

He's met with the MHRA, the UK regulatory agency who claim there are other SSRi withdrawal specialists based in the UK [but they cannot name who they are or where they are located] and provided them with a withdrawal protocol for SSRi's. Sadly, and predictably the withdrawal protocol fell on deaf ears and still remains on the table at the MHRA collecting dust and cobwebs.

It's safe to assume that the MHRA, who remember are fully funded by the pharmaceutical industry, are not one of Healy's biggest fans, to actually agree to meet with him back in 2010 must have stuck in the throats of those present. You see, the MHRA do not like being told how to steer their ship, they don't like being told that they are wrong. It's clearly evident, to me at least, that they are failing miserably in safeguarding human health. PIP implants and hip replacements are just two of the medical devices that have recently hit the news and highlighted the MHRA's failings. Prescription drugs such as Avandia, Vioxx, the class of SSRi antidepressants and benzos have also shown how the MHRA are failing to regulate properly.

Anyway, this post is about Healy's new ventures, namely his two new websites, Data Based Medicine Limited, which operates through its website RxISK.org and his personal website davidhealy.org.

Data Based Medicine Limited, of which Healy is the founder and Chief Executive Officer, aims to make medicines safer through online direct patient reporting of drug effects. Some may say it was created in direct opposition to the MHRA's current patient reporting system, the Yellow Card Scheme [YCS], a scheme that, over the years, has proven to be about as useful as a sailboat without a sail. The MHRA, of course, will argue that they have the best worldwide reporting system in place, in essence it's probably the best of a bad bunch and not something I'd shout from the rooftops if I were in charge of the MHRA.

Where Data Based Medicine Limited differ from the MHRA is that they intend to take anecdotal evidence and to present it as real based evidence. The YCS is, after all, an official anecdotal reporting service lacking in any follow-up or action.

The blurb for RxISK.org reads:

RxISK.org is your site to help make medicines safer for all of us. No-one knows drug side effects like the person who is taking a pill. Yet this voice is not heard. RxISK will provide a megaphone to you and your doctor to change the way we see drug safety.


Drug safety is an issue for us all. Prescription drugs are now a leading cause of death.


However, there is no evidence base for managing this new plague, nor are there any guidelines to help your doctor save you.


This means it takes time for the harmful effects of Vioxx, Avandia, and Prozac to be recognized.


You may have been told there is no evidence linking the treatment you are on to problems you are now having.


One reason there may be no evidence is because you and your doctor have been silenced. We need you to help us get across the message “We are not Anecdotes”. With your help, we're here to make medications safer for all of us.


Healy's other website, davidhealy.org, features articles, books, discussions and a regularly updated blog from Healy himself. His latest post is an eye-opener and relates to the way pharmaceutical companies admit and deny, almost in the same breath. That particular post can be read HERE.

If that weren't enough, Healy also has a new book [available March 2012] subtly entitled Pharmageddon,  "a searing indictment and forceful argument against the pharmaceuticalization of medicine..."


Once I land a copy of the book I'll review it and post on here.

All in all, the start of 2012 has been productive for David Healy. He's no martyr, he's just someone who has seen a problem and has set out to do something about it...without being answerable to those that created the problem in the first place.

MHRA Wishing To Call The Shots

MHRA: "Unless you have enquiries on an entirely different subject, we will not be able to respond to further comments from you."

I've received a reply from someone at the MHRA, once again they failed to add their name to it, preferring to write anonymously or as a ghost spokesperson [how brave]

For those that don't know I wrote to the MHRA regarding their recent recommendations to healthcare professionals in the UK. Their [ahem] innovative SSRi Learning Module tackles, amongst other things, severe SSRi withdrawal and the MHRA recommend to doctor's to seek the advice of "specialists".

In previous correspondence with them I asked just who these "specialists" were. They couldn't answer.

Well, they've made it abundantly clear to me now with their final say on the matter. Make note of the final line of their response.

Dear Mr Fiddaman,

We are responding to your email of 15 December.

Below, we provide responses to your further questions. They should be read alongside our replies of 7 December and 15 December to your enquiries.

1. For the record, just so we are clear, are the MHRA suggesting that severe SSRi withdrawal can now be defined as an illness?

Our introductory remarks make no reference to ‘SSRi withdrawal’. We are simply saying that, when necessary, non-specialist health professionals are able to access appropriate specialist services for diverse range of clinical circumstances.

Summaries of product characteristics list effects that may follow SSRI discontinuation under ‘Undesirable effects’.

2. Do you have instances where a health care professional has sought the advice or requested for an SSRi withdrawal specialist?

It is not in the MHRA’s remit to monitor the practice of health professionals. Details about an individual’s care are confidential between the individual and the health professional.

3. Have the MHRA liaised with health professional regulators to determine whether or not 'specialists' have the required qualifications in treating patients with severe SSRi withdrawal?

The MHRA regulates medicines and healthcare products and provides information on these. It is not for the MHRA to set standards for health professionals’ knowledge and expertise or to monitor them.

4. If I were to randomly select 10 healthcare practitioners and ask them if they could refer an SSRi withdrawal specialist to me and, for one reason or another, they could not provide me with any such specialist, would the MHRA then concede that there are, in fact, no SSRi withdrawal specialists with adequate training that can provide help for patients suffering severe SSRi withdrawal?

This point has been dealt with in our response of 15 December. The organisation of health care delivery does not fall under the MHRA’s responsibilities. Details about how health care services (including some specialist services) are organised and how individuals can access them are described by NHS Choices at http://www.nhs.uk/NHSEngland/AboutNHSservices/Pages/NHSServices.aspx

5. [No specific question asked]

We have responded elsewhere to these comments.

6. Professor David Healy has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Do the MHRA agree with professor Healy's findings?

We do acknowledge that there are some individuals who find it extremely difficult to discontinue treatment with SSRIs and for some it may take many years to stop treatment. We also know that it is not possible to predict those who may be at particular risk of experiencing withdrawal reactions on stopping treatment. However, we have not seen evidence to suggest that a significant number of people will never be able to stop taking SSRIs.

7. You state that the SSRi Learning module was “constructed by MHRA staff and drew on information and evidence in the public domain.”. Please list all references/evidences used.

The introduction to the learning module states:

This learning module is derived largely from summaries of product characteristics (which, in turn, are based on rigorous evaluation of submitted evidence). Supplementary sources such as guidelines from NICE are used to expand on advice on managing specific risks of SSRIs; however, general advice on the management of depression and other disorders is not covered.

The learning module lists key resources under ‘Further information’; these, together with references cited by them, were among the sources we used.

We have responded to your recent emails by providing all the information that falls within the scope of our work. A great deal of information is also available on our website. The answers to some of your questions clearly fall outside this Agency’s role and are not appropriate for us to tackle.

Unless you have enquiries on an entirely different subject, we will not be able to respond to further comments from you.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

My response to this:

How novel. Not content with the word 'vexatious' any more?

So, to recap, the MHRA will not answer any more questions relating to this query because my line of questioning is 'not appropriate for them to answer'. Do you only answer questions that you feel comfortable with?

Let's look at the facts.

The MHRA have conjured up SSRi withdrawal specialists. They remain confident that healthcare professionals can call upon the services of these specialists when faced with a patient who is suffering severe SSRi withdrawal.

When the MHRA have been asked to provide a list of specialists [that they have recommended] they cannot provide any such list.

The MHRA have, at least, acknowledged that there are some patients who may 'take many years to stop treatment'. They do not tell us why or offer any solutions other than recommendations to 'specialists' whom don't exist.

To cap it all, the MHRA are now refusing to answer any more questions on this matter. In truth, they cannot answer the questions because they don't have any answers. Any effort to answer would be an admittance of a failure to protect the public.

I put it to the MHRA that your SSRi Learning Module is deeply flawed and that you have made a huge error in recommending specialists that both you and I know do not exist. You are either buck-passing or lying.

If the MHRA lay claim to SSRi withdrawal specialists being available on the NHS then any queries regarding this claim should be answered with proof. At no time have the MHRA provided me with any proof that any such specialist exists.

My recommendation to the MHRA would be for a recall of the SSRi Learning Module and for them to list specialists for doctors to use. Also to explain to doctors that there are some patients who may take many years to stop taking their medication and to explain the reasons behind this.

It's absurd that an alternative is mentioned...yet not mentioned.

If I were to have a conversation with a food critique who was displeased at food offered to him at 'Restaurant A' and I told this critique that there was much better food elsewhere, he would naturally ask where.

If I stood there with a blank expression on my face and told him, "Um, I don't actually know", he would probably laugh in my face or serve my testicles on a platter with a rich red wine and a nice camembert. He certainly wouldn't see me as an expert on the matter of food.

The MHRA should not be making any recommendations to healthcare practitioners regarding SSRi withdrawal, it takes an expert to do that. Maybe the MHRA should have liaised with the ghost specialists they have recommended for healthcare practitioners to use - in truth, they did not because these specialists simply don't exist. To suggest that they do is akin to burying one's head in the sand and hoping the SSRi withdrawal problem will go away. It won't.

To put it mildly, when the MHRA are criticised they either call their critique 'vexatious' or just refuse to answer any more questions. They are the past masters of deflection and will sit around waiting for a solution to fall onto their laps. If they acknowledge that there are some patients who may take many years to stop taking an SSRi then they should, at the very least, contact the pharmaceutical industry who manufacture these drugs and ask them; a; why it takes so long for this group of people and b; how this group of people can be helped. They don't, they just sit around thumb twiddling and deflecting questions put to them by people who actually know the truth about SSRi withdrawal.

I've gone on record before stating that the MHRA are limp-wristed, that was a few years ago. My recent correspondence with you suggests to me that you continue to be limp-wristed and you continue to ignore the banner you fly under, "MHRA - safeguarding public health."

You are solely responsible for the advice you have handed out to healthcare practitioners re SSRi withdrawal. Your invention of SSRi withdrawal specialists is a matter of great concern to me and one that needs further investigation. I, for one, will seek further advice on how to extract the information I need, be it through government officials [highly unlikely] or the court of human rights.

Your arrogance is staggering and your knowledge on SSRi withdrawal is woefully inept.

Bob Fiddaman


Related articles:

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA In Buck-Passing Specialist Cahoots

MHRA - More on the Mysterious "Ghost Specialists"

Fid


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MHRA - More on the Mysterious "Ghost Specialists"

Following on from MHRA In Buck-Passing Specialist Cahoots, the MHRA have now replied to my series of questions. My follow up response can be seen at the foot of this post.

Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA.

Our reply of 7 December did not include a reference number as we (in the Central Enquiry Point) only assign reference numbers to requests under the Freedom of Information Act, and to requests passed to our Information Scientists for interrogation of our licensing database. We do not always include a name against our responses because the Central Enquiry Point often channels input from relevant technical experts in the Agency to prepare answers to enquiries. Colleagues in other parts of the Agency have prepared the response to your questions. However, in case it helps, I have included my name on this response.

Responses to each of your specific questions follow some general remarks.

You comment on our learning module on SSRIs. As we have mentioned, the learning module is written for health professionals and it should be read in conjunction with other information which covers the diagnosis and management of the relevant conditions.

Health professionals regularly work with others to give patients the best possible care—where necessary they routinely contact specialist services either for advice or with a request to take over the care of a patient. Once a patient is referred to such service, the specialist will treat the patient and, if necessary, contact other specialists within the network. This mechanism for care applies throughout the NHS whether a patient needs surgery, has cancer or suffers from other physical or mental illness.

The following address your specific questions:

1. You, as a regulator, do not have a list of these so-called specialists yet, without any qualms or vetting them, you are advising doctor's to use their services. Why?

Healthcare in the UK is regulated by several bodies each of which has a specific remit. While this Agency regulates medicines and healthcare products, others register health professionals and set standards for their competence (http://www.chre.org.uk/regulators). It is the health professional regulators who are responsible for setting standards of competence in line with current health knowledge and technology.

2. If I were to ask my GP to consult the RCP and RCGP will they be able to give him a list of specialists in SSRI dependence and withdrawal that he can consult?

A general practitioner will be very familiar with accessing specialist mental health services. These specialist services can then ensure that the patient is cared for by a specialist with appropriate skills.

3. Do you not feel, as a regulator, that you should, at the very least, see what training these specialists have had in the field of SSRi withdrawal?

The MHRA cannot encroach on the role of health professional regulators specifically created to set the standards of behaviour, competence and education of health professionals. The MHRA’s remit and expertise is in the regulation of medicines and healthcare products, not education and training of health professionals.

4. You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong?

During our discussion with Professor Healy he was clear that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes. We have liaised with both the BNF and NICE to stress the importance of highlighting the risk of withdrawal reactions in their respective publication and guidance. We provided input into the consultation for the most recent revision of the NICE depression guideline and have also inputted into changes to the section in the BNF on the risk of withdrawal reactions with SSRIs.

5. As I understand, you promised to liaise with Professor Healy should any more concerns arise re SSRi withdrawal. To my knowledge you have not liaised with him since your 2010 meeting with him. Why?

You are correct that we have not had further meetings with Professor Healy since 2010 but this is because no significant new data on the risk of withdrawal reactions and their management that alters our previous discussions has come to light since then and therefore further discussions have not been considered necessary.

1. What input did you receive from the pharmaceutical industry for your SSRI learning module?

No input was sought nor received from the pharmaceutical industry on the MHRA learning module on SSRIs. It was constructed by MHRA staff and drew on information and evidence in the public domain.

2. Please list any grants/funding you, may or may not have, received for your SSRI learning module.

The MHRA receives no external funding for this work. The material has been assembled by MHRA employees as part of their routine work and towards meeting the MHRA’s objective of providing information to healthcare professionals and promoting good practice in the safe use of medicines.

...and my response, sent today...



Follow-up questions to Ref: FOI 11/475

In reference to your 2nd para:

Health professionals regularly work with others to give patients the best possible care—where necessary they routinely contact specialist services either for advice or with a request to take over the care of a patient. Once a patient is referred to such service, the specialist will treat the patient and, if necessary, contact other specialists within the network. This mechanism for care applies throughout the NHS whether a patient needs surgery, has cancer or suffers from other physical or mental illness.

1. For the record, just so we are clear, are the MHRA suggesting that severe SSRi withdrawal can now be defined as an illness?

2. Do you have instances where a health care professional has sought the advice or requested for an SSRi withdrawal specialist?

3. You state that “It is the health professional regulators who are responsible for setting standards of competence in line with current health knowledge and technology” Have the MHRA liaised with health professional regulators to determine whether or not 'specialists' have the required qualifications in treating patients with severe SSRi withdrawal?

4. You state that “A general practitioner will be very familiar with accessing specialist mental health services. These specialist services can then ensure that the patient is cared for by a specialist with appropriate skills.” If I were to randomly select 10 healthcare practitioners and ask them if they could refer an SSRi withdrawal specialist to me and, for one reason or another, they could not provide me with any such specialist, would the MHRA then concede that there are, in fact, no SSRi withdrawal specialists with adequate training that can provide help for patients suffering severe SSRi withdrawal?

5. You state “The MHRA cannot encroach on the role of health professional regulators specifically created to set the standards of behaviour, competence and education of health professionals.” I disagree, if the MHRA are recommending specialists then the MHRA have a duty to patient healthcare that those specialists be adequately trained in the field of SSRi withdrawal. In essence, you are recommending a service that you do not know exists. In a nutshell, you are recommending to healthcare professionals to seek specialist advice from 'specialists' who have had no training or have received no guidelines to help patients suffering severe SSRi withdrawal.

6. You state “During our discussion with Professor Healy he was clear that the focus should be on highlighting to GPs that withdrawal reactions could be serious and prolonged in some patients and agreed that NICE and the BNF would be reasonable routes. We have liaised with both the BNF and NICE to stress the importance of highlighting the risk of withdrawal reactions in their respective publication and guidance.” With respect, the question was - 'You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong?' I'll ask again. Professor David Healy has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Do the MHRA agree with professor Healy's findings?

7. You state that the SSRi Learning module was “constructed by MHRA staff and drew on information and evidence in the public domain.”. Please list all references/evidences used.

MHRA In Buck-Passing Specialist Cahoots

Buck-passing:  - The shifting of responsibility or blame to another.

Vague - Not clearly expressed; inexplicit.

I used to liaise with the MHRA. There was a time when they sought my advice on the Yellow Card reporting system. I'm not the only person or organisation they sought help from.

I called it quits with the MHRA when they would not admit that Seroxat [Paxil] was a teratogen. I severed ties with them, save for the odd Freedom of Information request.

Regular readers will know of the recent SSRi Learning Module that the MHRA have apparently devised for healthcare practitioners. I criticized this module in three separate posts on this blog [Links at foot of this article]

What was irksome for me was the buck-passing that was apparent throughout the module. On the subject of severe SSRi withdrawal the MHRA are telling healthcare practitioners to recommend "specialists" to patients.

With this in mind I sent the following to the MHRA:

Can the MHRA provide me with a list of specialists experienced in SSRi withdrawal that are a; in the UK and b; available on the NHS.

The MHRA, as transparent as ever, have replied:

Dear Mr Fiddaman,

You ask for a list of specialists with experience of managing SSRI withdrawal.

The MHRA regulates the quality, safety and efficacy of medicines and medical devices, but it does not regulate health professionals. We do not, therefore, hold lists of individual health professionals of the type you seek.

Health professionals are registered to practice by their statutory regulatory bodies (such as the General Medical Council and the Nursing and Midwifery Council). Those who specialise are further accredited by their professional institutions (such as the Royal College of General Practitioners and the Royal College of Psychiatrists).

Turning to SSRI withdrawal, health professionals have recourse to summaries of product characteristics, which give information on SSRI withdrawal. Further, in July, the MHRA published information on selective serotonin reuptake inhibitors and serotonin and noradrenaline reuptake inhibitors (link below), which has a section on ‘SSRIs/SNRIs and the risk of withdrawal reactions’. It links to several documents on advice emerging from detailed review of evidence on SSRI withdrawal undertaken by the MHRA and its Expert Working Groups.

More recently, the MHRA’s learning module on the SSRIs briefly outlines points for health professionals to bear in mind about SSRI treatment. The learning module, developed for healthcare professionals, should be read in conjunction with other information such as treatment guidelines.

Withdrawal effects vary from person to person and call for individual management guided by advice in summaries of product characteristics and the background information we have published. If necessary, health professionals can request advice from local specialist mental health services.

Because I feel this should be out in the open, I am adding my response to the above on my blog. I feel the MHRA are once again shirking their responsibilities here and simply playing the game of 'pass the buck'.

My response:

Dear Whoever,

Firstly, I apologise for not naming you in person, there was no sig at the foot of the email you sent me. There was also no reference number to quote.

I am well aware of your SSRi Learning module and also aware that you are recommending doctors to advise patients, who are struggling severe withdrawal, to seek 'specialist' advice.

Couple of points.

You, as a regulator, do not have a list of these so-called specialists yet, without any qualms or vetting them, you are advising doctor's to use their services. Why?

If I were to ask my GP to consult the RCP and RCGP will they be able to give him a list of specialists in SSRI dependence and withdrawal that he can consult?

Do you not feel, as a regulator, that you should, at the very least, see what training these specialists have had in the field of SSRi withdrawal?

To be brutally honest, your SSRi Learning Module is, quite frankly, poor advice. You will be no doubt aware of my criticism of it on my blog?

You have, in the past, met with stakeholders with regard to antidepressants [SSRi's] - it appears you have ignored those meetings in favour of what the manufacturers of these drugs have to offer.

You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong? I would like a straight answer on this please.

As I understand, you promised to liaise with Professor Healy should any more concerns arise re SSRi withdrawal. To my knowledge you have not liaised with him since your 2010 meeting with him. Why?
There is no withdrawal protocol for SSRi's, you can't offer it neither can the manufacturers, it's left, in the main, to former patients who have struggled at the hands of SSRi withdrawal.

In essence, your recommendations to healthcare professionals via your SSRi Learning Module regarding these 'specialists' has been recommended without first researching these specialists. That's poor management on your part and once again you, the regulator, are putting the onus on healthcare professionals to make a decision.

Obviously my next question will fall under the Freedom of Information Act.

1. What input did you receive from the pharmaceutical industry for your SSRi Learning Module?

 2. Please list any grants/funding you, may or may not have, received for your SSRi Learning Module.

To recap:

 Non FOI questions:

1. You, as a regulator, do not have a list of these so-called specialists yet, without any qualms or vetting them, you are advising doctor's to use their services. Why?

2. If I were to ask my GP to consult the RCP and RCGP will they be able to give him a list of specialists in SSRI dependence and withdrawal that he can consult?

3. Do you not feel, as a regulator, that you should, at the very least, see what training these specialists have had in the field of SSRi withdrawal?

4. You, at my request, also met with Professor David Healy who has acknowledged that there are a significant number of people on SSRi's that will never be able to stop. Have you relayed this information to healthcare specialists, do you agree with Professor Healy's advice or do you think the advice is wrong?

5. As I understand, you promised to liaise with Professor Healy should any more concerns arise re SSRi withdrawal. To my knowledge you have not liaised with him since your 2010 meeting with him. Why?

The following two questions fall within the remit of the Freedom of Information Act.

1. What input did you receive from the pharmaceutical industry for your SSRi Learning Module?

2. Please list any grants/funding you, may or may not have, received for your SSRi Learning Module.

Bob Fiddaman.

PS: I'd appreciate a reference number for this continued correspondence.

The reason I am adamant to get to the bottom of this matter stems from the three critiques I wrote concerning the MHRA's SSRi Learning Module which can be read at the following links:


MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine